Type 1 Diabetes3MsNCT06275412
Family Intervention for Black Teens With Type 1 Diabetes
A study testing The 3Ms 2.0 Intervention in people with Type 1 Diabetes and Family Relations, run by Wayne State University at 4 sites in United States.
Trial summary
The purpose of this study is to conduct a multicenter, randomized effectiveness trial of The 3Ms 2.0 compared to an educational control condition for improving adolescent glycemic control and diabetes-related family relationships and reducing primary caregiver diabetes-related distress among Black adolescents with… Read more about this study
- Who is it for?
- Ages 10 to 14 years
- Conditions the study is for
- Type 1 Diabetes, Family Relations
- What is being tested?
- The 3Ms 2.0 Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 216 participants
- Where
- 4 sitesUnited States
- Study dates
- 16 Sep 2024to 30 Apr 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age: 10 years, 0 months - 14 years, 11 months
- Diagnosed with Type 1 diabetes
- Diagnosed for at least 6 months
- Black
- Primary caregiver willing to participate
- Residence within 30 miles of a recruitment site
- Caregiver ownership of an Internet-enabled device (cell phone, laptop or desktop computer, tablet, etc)
Who cannot join
- Mental health conditions that might compromise data integrity (e.g., developmental delay, schizophrenia, psychosis, current suicidality, homicidality)
- Co-morbid medical condition resulting in atypical diabetes management (e.g., cystic fibrosis)
- Inability to speak or read English
- Child is in out-of-home placement
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States4 sites, 4 recruiting
- Recruiting
Wayne Pediatrics
Detroit, Michigan, 48201
Jillian Sjostrom, 3135776997, jrhind@med.wayne.edu
Deborah A Ellis, Ph.D.
- Recruiting
LeBonheur Children's Hospital
Memphis, Tennessee, 38103
Kristoffer S Berlin, Ph.D., ksberlin@memphis.edu
Kathryn Sumpter, MD
- Recruiting
University of Tennessee Health Science Center-Memphis
Memphis, Tennessee, 38163
Kristoffer S Berlin, Ph.D., ksberlin@memphis.edu
Kathryn Sumpter, MD
- Recruiting
Children's National Hospital
Washington D.C., District of Columbia, 20010
Angelica Eddington, Ph.D., ABPP, 202-476-2342, aeddington@childrensnational.org
Angelica Eddington, Ph.D., ABPP
About this study
Official title: Family mHealth Intervention to Improve Health Outcomes in Black Youth With Type 1 Diabetes
The purpose of this study is to conduct a multicenter, randomized effectiveness trial of The 3Ms 2.0 compared to an educational control condition for improving adolescent glycemic control and diabetes-related family relationships and reducing primary caregiver diabetes-related distress among Black adolescents with type 1 diabetes (T1D) and their primary caregivers. The proposed study would develop and test The 3Ms 2.0 adapted intervention when delivered using a mobile health approach (accessed via parents' cell phone). The intervention will also include new family intervention content (videoclips and text messages).
Read the detailed description
The proposed study is a multi-center randomized controlled trial (RCT) examining the efficacy of The 3Ms 2.0 compared to an educational attention control condition (EAC) for improving adolescent glycemic control and diabetes-related family relationships and reducing primary caregiver diabetes-related distress among Black adolescents with type 1 diabetes (T1D) and their primary caregivers. A randomized, controlled, repeated measures design will be used. The study will use a sample of 216 Black adolescent-caregiver dyads. Participants will be recruited at two sites (University of Tennessee Health Sciences Center/ LeBonheur Children's Hospital and Children's National Hospital in Washington, DC). 108 families will be recruited at each of the two sites. Wayne State University (WSU) will function as the coordinating center for the trial and will be responsible for overseeing the adequacy of all aspects of trial management.
Participants will be randomly assigned in a 1:1 ratio to receive The 3Ms 2.0 plus standard medical care or EAC plus standard medical care. In the 3Ms 2.0 condition, primary caregivers will receive a brief (10-20 minute) 3 session computer-delivered intervention via their mobile device. The intervention is designed to increase parental daily supervision of adolescent diabetes management. In the control condition, primary caregivers will also receive 3 brief computer-delivered sessions where the content is information and facts about type 1 diabetes. The intervention content will be available to the primary caregiver during a six month window and can be completed at their convenience.
Data collection occurs in the families' home at baseline (T1), three months post-baseline (corresponding with the midpoint of the intervention window) (T2), six months post- baseline (corresponding with the end of the intervention window) (T3) and 12 months post-baseline (T4). Data completion can be completed via the Internet should families live outside a reasonable driving distance from the recruitment site. Data collection is completed by the adolescent and caregiver on a tablet computer and includes questionnaires to assess adolescent diabetes management, parental supervision of diabetes management, family relationships and youth quality of life. Blood will also be collected to measure HbA1c (mean blood glucose level). Medical record data will also be collected.
The data analyses will be intent-to-treat, meaning that all randomized participants are included regardless of the intervention dose received. Trial data will analyzed using the linear mixed effect model (LME) for repeated measures.
- Conditions
- Type 1 Diabetes, Family Relations
- Being tested
- The 3Ms 2.0 Intervention, Educational Attention Control (EAC)
- Keywords
- Type 1 Diabetes, mobile health, Family-based intervention
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The 3Ms 2.0 InterventionBehavioural
The 3Ms is a culturally tailored, mHealth intervention for primary caregivers of Black adolescents with T1D focused on promoting daily parental monitoring of adolescent diabetes care and delivered via an Internet platform, Computer Intervention Authoring System (CIAS). The intervention content is based on the Information-Motivation-Behavioral Skills (IMB) model. Caregivers randomized to The 3Ms receive 3 sessions. The caregiver is guided through each session by an interactive and emotive three-dimensional narrator that reads and speaks aloud. Additional intervention content includes brief videoclips to provide skills demonstrations of supportive parenting practices related to diabetes care and text message reminders. Each session is no more than 20 minutes in length. The intervention is delivered over a three-month window, with the two follow-up sessions available to be accessed by the caregiver at one-month intervals after completion of the initial session.
Educational Attention Control (EAC)Behavioural
The EAC intervention consists of three sessions delivered in an mHealth format via the CIAS internet platform over three months, with access for a maximum of six months. EAC provides structured information on topics of interest to caregivers of adolescents with T1D such as travelling with diabetes, or emergency preparedness for persons with diabetes. All participants receive their standard medical care.
| Study group | Role | What they receive |
|---|---|---|
| Educational Attention Control (EAC) + Standard Medical Care | Active comparator | Not described Receives: Behavioral: Educational Attention Control (EAC) |
| The 3Ms 2.0 Intervention + Standard Medical Care | Experimental | Not described Receives: Behavioral: The 3Ms 2.0 Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycemic Control
Hemoglobin A1c (HbA1c)
Measured: Baseline, 3 months, 6 months, and 12 months
Secondary outcomes (4)
Caregiver Diabetes Distress
Parent Problem Areas in Diabetes (P-PAID). The questionnaire's items are rated on a scale from 1 (not a problem) to 6 (serious problem). Higher scores reflect more diabetes distress
Measured: Baseline, 3 months, 6 months, and 12 months
Diabetes-Specific Family Conflict
Diabetes Family Conflict Scale-Short Form (DFCS-SF). The questionnaire's items are rated on a scale from 1 (almost never) to 3 (almost always). Higher scores reflect more family conflict
Measured: Baseline, 3 months, 6 months, and 12 months
Diabetes-Specific Parental Monitoring
Parental Monitoring of Diabetes Care-Revised (PMDC-R). The questionnaire's items are rated from 1 to 5, with higher scores reflecting higher parental monitoring
Measured: Baseline, 3 months, 6 months and 12 months
Diabetes-Specific Family Support
Diabetes Social Support Questionnaire-Family (DSSQ-Family). Items reflecting frequency of support are rated from 0 (never) to 5 (at least once a day). Items reflecting helpfulness of support are rated from 0(not at all) to 2 (very). Higher scores reflect more frequent family support and more helpful family support
Measured: Baseline, 3 months, 6 months and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2024
- Study start16 Sep 2024
- Primary completion30 Apr 2028 (estimated)
- Study completion30 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 216 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wayne State University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Responsible party
- Principal investigator, Deborah Ellis, Ph.D., Wayne State University
- Investigators
- Deborah A Ellis, Ph.D., Principal investigator, Wayne State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06275412
- Sponsor's protocol ID
- IRB-23-04-5675
- Other IDs
- 5R01MD018583-02
- Acronym
- 3Ms
- Status last verified
- Aug 2026
- First submitted
- 8 Feb 2024
- Last updated
- 27 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Identifiers will be removed from the data prior to any release of the dataset. The final data set will include data obtained from medical records, data obtained directly from participants on diabetes health status, behavioral data, and intervention data. Participants in the trial will be recruited through two children's hospitals. Even though the final dataset will not contain identifiers, given the relatively small sample size and focus on Black youth, there remains the possibility of deductive identification of subjects with unusual characteristics (i.e. high number hospital admissions).
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Family mHealth Intervention to Improve Health Outcomes in Black Youth With Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT06275412
- Acronym / sponsor ID
- 3Ms / IRB-23-04-5675
- Conditions
- Type 1 Diabetes, Family Relations
- Keywords
- Type 1 Diabetes, mobile health, Family-based intervention
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 216 participants (estimated)
- Lead sponsor
- Wayne State UniversityUniversity, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Study start
- 16 Sep 2024 (actual)
- Primary completion
- 30 Apr 2028 (estimated)
- Study completion
- 30 Apr 2028 (estimated)
- First posted
- 23 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to conduct a multicenter, randomized effectiveness trial of The 3Ms 2.0 compared to an educational control condition for improving adolescent glycemic control and diabetes-related family relationships and reducing primary caregiver diabetes-related distress among Black adolescents with type 1 diabetes (T1D) and their primary caregivers. The proposed study would develop and test The 3Ms 2.0 adapted intervention when delivered using a mobile health approach (accessed via parents' cell phone). The intervention will also include new family intervention content (videoclips and text messages).
Detailed description
The proposed study is a multi-center randomized controlled trial (RCT) examining the efficacy of The 3Ms 2.0 compared to an educational attention control condition (EAC) for improving adolescent glycemic control and diabetes-related family relationships and reducing primary caregiver diabetes-related distress among Black adolescents with type 1 diabetes (T1D) and their primary caregivers. A randomized, controlled, repeated measures design will be used. The study will use a sample of 216 Black adolescent-caregiver dyads. Participants will be recruited at two sites (University of Tennessee Health Sciences Center/ LeBonheur Children's Hospital and Children's National Hospital in Washington, DC). 108 families will be recruited at each of the two sites. Wayne State University (WSU) will function as the coordinating center for the trial and will be responsible for overseeing the adequacy of all aspects of trial management.
Participants will be randomly assigned in a 1:1 ratio to receive The 3Ms 2.0 plus standard medical care or EAC plus standard medical care. In the 3Ms 2.0 condition, primary caregivers will receive a brief (10-20 minute) 3 session computer-delivered intervention via their mobile device. The intervention is designed to increase parental daily supervision of adolescent diabetes management. In the control condition, primary caregivers will also receive 3 brief computer-delivered sessions where the content is information and facts about type 1 diabetes. The intervention content will be available to the primary caregiver during a six month window and can be completed at their convenience.
Data collection occurs in the families' home at baseline (T1), three months post-baseline (corresponding with the midpoint of the intervention window) (T2), six months post- baseline (corresponding with the end of the intervention window) (T3) and 12 months post-baseline (T4). Data completion can be completed via the Internet should families live outside a reasonable driving distance from the recruitment site. Data collection is completed by the adolescent and caregiver on a tablet computer and includes questionnaires to assess adolescent diabetes management, parental supervision of diabetes management, family relationships and youth quality of life. Blood will also be collected to measure HbA1c (mean blood glucose level). Medical record data will also be collected.
The data analyses will be intent-to-treat, meaning that all randomized participants are included regardless of the intervention dose received. Trial data will analyzed using the linear mixed effect model (LME) for repeated measures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Educational Attention Control (EAC) + Standard Medical Care | Active comparator | Behavioral: Educational Attention Control (EAC) |
| The 3Ms 2.0 Intervention + Standard Medical Care | Experimental | Behavioral: The 3Ms 2.0 Intervention |
Who may qualify
- Ages
- 10 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Age: 10 years, 0 months - 14 years, 11 months
- Diagnosed with Type 1 diabetes
- Diagnosed for at least 6 months
- Black
- Primary caregiver willing to participate
Key exclusion criteria (4 listed)
- Mental health conditions that might compromise data integrity (e.g., developmental delay, schizophrenia, psychosis, current suicidality, homicidality)
- Co-morbid medical condition resulting in atypical diabetes management (e.g., cystic fibrosis)
- Inability to speak or read English
- Child is in out-of-home placement
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The 3Ms 2.0 InterventionThe 3Ms is a culturally tailored, mHealth intervention for primary caregivers of Black adolescents with T1D focused on promoting daily parental monitoring of adolescent diabetes care and delivered via an Internet platform, Computer Intervention Authoring System (CIAS). The intervention content is based on the Information-Motivation-Behavioral Skills (IMB) model. Caregivers randomized to The 3Ms receive 3 sessions. The caregiver is guided through each session by an interactive and emotive three-dimensional narrator that reads and speaks aloud. Additional intervention content includes brief videoclips to provide skills demonstrations of supportive parenting practices related to diabetes care and text message reminders. Each session is no more than 20 minutes in length. The intervention is delivered over a three-month window, with the two follow-up sessions available to be accessed by the caregiver at one-month intervals after completion of the initial session. | Behavioural | The 3Ms 2.0 Intervention + Standard Medical Care |
| Educational Attention Control (EAC)The EAC intervention consists of three sessions delivered in an mHealth format via the CIAS internet platform over three months, with access for a maximum of six months. EAC provides structured information on topics of interest to caregivers of adolescents with T1D such as travelling with diabetes, or emergency preparedness for persons with diabetes. All participants receive their standard medical care. | Behavioural | Educational Attention Control (EAC) + Standard Medical Care |
Primary outcome
Glycemic Control
Time frame: Baseline, 3 months, 6 months, and 12 months
Hemoglobin A1c (HbA1c)
4 secondary outcomes
Caregiver Diabetes Distress
Time frame: Baseline, 3 months, 6 months, and 12 months
Diabetes-Specific Family Conflict
Time frame: Baseline, 3 months, 6 months, and 12 months
Diabetes-Specific Parental Monitoring
Time frame: Baseline, 3 months, 6 months and 12 months
Diabetes-Specific Family Support
Time frame: Baseline, 3 months, 6 months and 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2026.
- Individual participant dataSharing planned: Yes. Identifiers will be removed from the data prior to any release of the dataset. The final data set will include data obtained from medical records, data obtained directly from participants on diabetes health status, behavioral data, and intervention data. Participants in the trial will be recruited through two children's hospitals. Even though the final dataset will not contain identifiers, given the relatively small sample size and focus on Black youth, there remains the possibility of deductive identification of subjects with unusual characteristics (i.e. high number hospital admissions).
Related trials for Type 1 Diabetes
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
RecruitingPhase 1
Pharmacokinetics, Safety, and Immunogenicity Comparison of Bmab1700 and Opdivo® as Adjuvant Monotherapy in Participants With Melanoma
Melanoma
Active, not recruitingPhase 2
A Study of Botensilimab and Balstilimab for the Treatment of Colorectal Cancer
Metastatic Colorectal Cancer
Not yet recruiting
Inter-Arm Differences in Continuous Glucose Monitor Readings in Adults With Diabetes
Continuous Glucose Monitoring, Type 1 Diabetes
RecruitingObservational study
Estimated Risk of Preeclampsia in the First Trimester and Its Association With Subclinical Atherosclerosis and Cardiovascular Risk in Women With Type 1 Diabetes
Type 1 Diabetes, Preeclampsia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Deborah A Ellis, Ph.D. principal investigator
Wayne State University
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The 3Ms 2.0 Intervention in people with Type 1 Diabetes and Family Relations, run by Wayne State University at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Deborah A Ellis, Ph.D. (313-577-1055, dellis@med.wayne.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glycemic Control (time frame: Baseline, 3 months, 6 months, and 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2026.